Identity
- Trade Name
- ELISA Rubella IgG Q Test System FDA UDI
- Generic Name
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Rubella IgG Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- Q9Z9801GB FDA UDI
- Description
- The ZEUS ELISA Rubella IgG Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- Q9Z9801GB FDA UDI
- Primary DI / UDI-DI
- 00845533001014 FDA UDI
- GMDN Term
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ELISA Rubella IgG Q Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- BioSign® Rubella card — PRINCETON BIOMEDITECH CORP. · Class II
- QMedix™ — Diagnostic Automation, Inc. · Class II
- Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- Elecsys Rubella IgG — Roche Diagnostics Corp. · Class II
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
- VIDAS® RUB IgG — BIOMERIEUX , INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 948184fd-1b71-4313-80dc-cc20259081bb 35 fields · synced May 30, 2026